21 U.S. Code § 360h–1 - Program to improve the device recall system

(1)establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;

(2)clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;

(3)develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and

(4)document the basis for each termination by the Food and Drug Administration of a device recall.

(b) Assessment content

The program established under subsection (a)(1) shall, at a minimum, identify—

(1)trends in the number and types of device recalls;

(2)devices that are most frequently the subject of a recall; and

(3)underlying causes of device recalls.

(c) Termination of recalls

The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.

(d) Definition

In this section, the term “recall” means—

(1)the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) ofsection
360h of this title; or

(2)the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section
360i(g) of this title.